Temperature, humidity, pressure loggers for high temperature management software, that meets all requirements of FDA 21 CFR Part 11 regulations

SterilDisk (all versions), PasteurDisk Can, SterilDisk Can, S-Disk J, P-Micro (all versions), S-Micro (all versions), P-Radio, S-Radio, S-MicroW (all versions), L-Disk, RHTemp (all versions), PressureDisk (all versions) management software, supports DiskInterface HS Mini, DiskInterface HS, Universal Multibay and USB Radio Receiver. Downloadable from Tecnosoft website and works with its hardware protection key only.

The software meets all requirements of FDA 21 CFR Part 11 regulations and presents some peculiar features meeting some requirements of particular applications. It is dedicated to process and instrument, particularly autoclaves, validation.

Video

Main features

  • Data in the devices not editable
  • Data in software not editable
  • Access for each user throgh login and password
  • Client/server setup and shared database
  • Multi-user access
  • Multi-level users, with different functions for each one
  • Customers and validated Instruments database for validators activity
  • Logbook: recording, not editable, of all carried out operations
  • Data analysis through pre-set or customizable parametres
  • Possibility of pre and post mission comments
  • Vasualization in graph, with zoom, and table
  • Multi graph analysis
  • Graph divided into Sections with analysis and statistics for each section
  • Synchronized data table with statistics for each acquisition: maximum, minimum, average, maximum-minimum, maximum-maverage, average-minimum
  • Theoretical temperature calculation based on pressure in satured steam environment
  • Print of customizable reports
  • Data and reports export in HTML and XLS (MS Excel) format

The system

System with TS Manager is made up by:

  • SterilDisk (all versions) / P-Micro (all versions) / S-Micro (all versions) / S-Disk J (all versions) / S-MicroW (all versions) / L-Disk (all versions) / P-Radio (all versions) / S-Radio (all versions) / RHTemp (all versions) / PressureDisk (all versions)
  • DiskInterface HS Mini / DiskInterface HS / Universal Multibay

Operating systems Windows XP, Vista, 7, 8, 10 (32, 64 bit)
Regulation compatibility FDA 21 CFR Part 11
Data loggers supported SterilDisk (all versions), PasteurDisk Can, SterilDisk Can, P-Micro (all versions), S-Micro (all versions), S-Disk J, S-MicroW (all versions), L-Disk (all versions), RHTemp (all versions), PressureDisk (all versions), P-Radio (all versions), S-Radio (all v
Data management Client/server database with single missions, groups, customers, instruments, devices, programming profiles
Data display Graph (with zoom) and table (exportable into Excel and HTML), markers for process start and end, printed report of all the data, Multi graph
Customizable parameters Acquisition step, mission duration, analyisi type (lethality with Z and reference temperature values setting, Overkilling for validation)
Calculated parameters Lethality (F0, PU. A0 etc.)
Accessories DiskInterface HS Mini, DiskInterface HS, Universal Multibay
Languages Italian, English, German

Documentation

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